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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K103204
Device Name SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
Applicant
SOLARC SYSTEMS INC.
1515 SNOW VALLEY ROAD
MINESING,ONTARIO,  CA L0L 1Y3
Applicant Contact BRUCE ELLIOTT
Correspondent
SOLARC SYSTEMS INC.
1515 SNOW VALLEY ROAD
MINESING,ONTARIO,  CA L0L 1Y3
Correspondent Contact BRUCE ELLIOTT
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/01/2010
Decision Date 04/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT00771732
Reviewed by Third Party No
Combination Product No
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